BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEOARTHROSCOPE, HD, 4MM X 30 DEG

    MDR report key: 6955200 · Received October 17, 2017

    Report

    Report Number
    3003604053-2017-00253
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    October 29, 2014
    Report Date
    October 17, 2017
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HXR
    PMA / PMN Number
    K971253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCOPE VIEW WAS BLACKED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733875 VIDEOARTHROSCOPE, HD, 4MM X 30 DEG SPATULA, ORTHOPEDIC HXR SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1